Exercise Training in Sarcoidosis (EXTRAS Study)

Sarcoidosis Clinical Trial

Official title:

EXercise TRAining in Sarcoidosis (EXTRAS Study): A Prospective, Randomized, Controlled, Crossover Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00099424
• Other study ID #: ML2563
• Status: Completed
• Phase: N/A
• First received: December 13, 2004
• Last updated: June 4, 2008
• Start date: February 2004
• Est. completion date: August 2005

Study information

• Verified date: June 2008
• Source: University Hospital, Gasthuisberg
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
• Study type: Interventional

Clinical Trial Summary

Exercise intolerance and reduced health status have been found in patients with sarcoidosis and has been related to skeletal muscle weakness. The present researchers reason that skeletal muscle weakness is, at least in part, related to physical inactivity and therefore partially reversible following a structured exercise training program. Nevertheless, the effects of exercise training have never been studied in patients with sarcoidosis. Therefore, the present study is undertaken to explore the effects of exercise training in patients with sarcoidosis. A priori, the following hypotheses are formulated:

• A 12-week exercise training program improves health status, quality of life and exercise capacity in patients with sarcoidosis as compared to sarcoidosis patients without exercise intervention.

• A 12-week exercise training program improves skeletal muscle function and reduces complaints of anxiety and depression in patients with sarcoidosis as compared to sarcoidosis patients without exercise intervention.

• A 12-week exercise training program reduces circulating levels of inflammatory markers in patients with sarcoidosis as compared to sarcoidosis patients without exercise intervention.

Description:

The EXTRAS study is a prospective, randomized, controlled, 24-week crossover clinical trial in which the participants are randomly assigned to receive 12 weeks of dynamic resistance and whole-body endurance exercises followed by 12 weeks without intervention or vice versa. Consenting participants will be assessed at baseline (before randomization, week 0) and at weeks 12 and 24.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Main diagnosis: previously diagnosed sarcoidosis according to the latest ATS/ERS/WASOG statement on sarcoidosis (AJRCCM 1999)

Exclusion Criteria:

• A history of neurosarcoidosis

• Undergoing structured exercise training at the time of enrollment or in the preceding 6 months

• Current participation in a pharmacological study

• Cardiovascular abnormalities on the ECG during baseline peak exercise test

• A 'normal' baseline peak oxygen uptake (=90% of the predicted values) in combination with a 'normal' quadriceps peak torque or distance walked in 6 minutes

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind

Related Conditions & MeSH terms

• Sarcoidosis

Intervention

Behavioral:
• High-intensity exercise training

Locations

Country	Name	City	State
Belgium	University Hospital Leuven	Leuven	Vlaams-Brabant

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Gasthuisberg

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Health status: Medical Outcomes Study 36-Item Short-Form Health Survey
Primary	Disease-specific quality of life: Sarcoidosis Health Questionnaire
Primary	Peak exercise capacity: a symptom-limited peak exercise test on a cycle ergometer
Primary	Functional exercise capacity (I): a symptom-limited endurance cycling test at 70% of the achieved peak external load
Primary	Functional exercise capacity (II): the distance walked in 6 minutes
Secondary	Pulmonary function: forced vital capacity and transfer factor for carbon monoxide
Secondary	Muscle function: isometric quadriceps femoris muscle peak torque
Secondary	Systemic inflammation: circulating levels of IL-2, sIL-2r, IL-6, IL-8, TNF-alpha, sTNFR-p55, sTNFR-p75
Secondary	Anxiety and depression: Hospital Anxiety and Depression Scale
Secondary	Health-related quality of life (I): Chronic Respiratory Disease Questionnaire
Secondary	Health-related quality of life (II): St. George's Respiratory Questionnaire